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Lipitor (Atorvastatin Calcium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, LIPITOR is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke
  • Reduce the risk for revascularization procedures and angina

In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke

In patients with clinically evident coronary heart disease, LIPITOR is indicated to:

  • Reduce the risk of non-fatal myocardial infarction
  • Reduce the risk of fatal and non-fatal stroke
  • Reduce the risk for revascularization procedures
  • Reduce the risk of hospitalization for CHF
  • Reduce the risk of angina

Hypercholesterolemia

LIPITOR is indicated:

  • as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
  • as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);
  • for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
  • to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable;
  • as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a.LDL-C remains ≥ 190 mg/dL or
  • b.LDL-C remains ≥ 160 mg/dL and:
      there is a positive family history of premature cardiovascular disease or
    • two or more other CVD risk factors are present in the pediatric patient

Therapy with lipid-altering agents should be a component of multiple-risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate (see National Cholesterol Education Program (NCEP) Guidelines, summarized in Table 7).

TABLE 7. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
Risk CategoryLDL-C Goal
(mg/dL)
LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)LDL Level at Which to Consider Drug Therapy (mg/dL)
CHD CHD, coronary heart disease or CHD risk equivalents
(10-year risk >20%)
<100≥100≥130
(100–129: drug optional) Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgement also may call for deferring drug therapy in this subcategory.
2+ Risk Factors
(10-year risk ≤20%)
<130≥130 10-year risk 10%–20%: ≥130
10-year risk <10%: ≥ 160
0–1 Risk factor Almost all people with 0–1 risk factor have 10-year risk <10%; thus, 10-year risk assessment in people with 0–1 risk factor is not necessary.<160≥160≥190
(160–189: LDL-lowering drug optional)

After the LDL-C goal has been achieved, if the TG is still ≥200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.

Prior to initiating therapy with LIPITOR, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total-C, LDL-C, HDL-C, and TG. For patients with TG <400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = total-C - (0.20 × [TG] + HDL-C). For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation.

LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below:

CategoryTotal-C (mg/dL)LDL-C (mg/dL)
Acceptable<170<110
Borderline170–199110–129
High≥200≥130

DOSAGE AND ADMINISTRATION

The patient should be placed on a standard cholesterol-lowering diet before receiving LIPITOR and should continue on this diet during treatment with LIPITOR.

Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The recommended starting dose of LIPITOR is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. LIPITOR can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of LIPITOR should be individualized according to patient characteristics such as goal of therapy and response (see NCEP Guidelines, summarized in Table 7). After initiation and/or upon titration of LIPITOR, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should total-C be used to monitor therapy.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10–17 years of age)

The recommended starting dose of LIPITOR is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel GuidelinesNational Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children Adolescents, Pediatrics. 89(3):495–501. 1992., CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE). Adjustments should be made at intervals of 4 weeks or more.

Homozygous Familial Hypercholesterolemia

The dosage of LIPITOR in patients with homozygous FH is 10 to 80 mg daily. LIPITOR should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Concomitant Lipid Lowering Therapy

LIPITOR may be used in combination with a bile acid binding resin for additive effect. The combination of HMG-CoA reductase inhibitors and fibrates should generally be avoided (see WARNINGS, Skeletal Muscle, and PRECAUTIONS, Drug Interactions for other drug-drug interactions).

Dosage in Patients With Renal Insufficiency

Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Dosage in Patients Taking Cyclosporine, Clarithromycin or A Combination of Ritonavir plus Saquinavir or Lopinavir plus Ritonavir

In patients taking cyclosporine, therapy should be limited to LIPITOR 10 mg once daily. In patients taking clarithromycin or in patients with HIV taking a combination of ritonavir plus saquinavir or lopinavir plus ritonavir, for doses of atorvastatin exceeding 20 mg appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed (see WARNINGS, Skeletal Muscle, and PRECAUTIONS, Drug Interactions).

HOW SUPPLIED

LIPITOR® (atorvastatin calcium) is supplied as white, elliptical, film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.

10 mg tablets: coded "PD 155" on one side and "10" on the other.

NDC 0071-0155-23 bottles of 90

NDC 0071-0155-34 bottles of 5000

NDC 0071-0155-40 10 × 10 unit dose blisters

20 mg tablets: coded "PD 156" on one side and "20" on the other.

NDC 0071-0156-23 bottles of 90

NDC 0071-0156-40 10 × 10 unit dose blisters

NDC 0071-0156-94 bottles of 5000

40 mg tablets: coded "PD 157" on one side and "40" on the other.

NDC 0071-0157-23 bottles of 90

NDC 0071-0157-73 bottles of 500

NDC 0071-0157-88 bottles of 2500

NDC 0071-0157-40 10 × 10 unit dose blisters

80 mg tablets: coded "PD 158" on one side and "80" on the other.

NDC 0071-0158-23 bottles of 90

NDC 0071-0158-73 bottles of 500

NDC 0071-0158-88 bottles of 2500

NDC 0071-0158-92 8 × 8 unit dose blisters

Storage

Store at controlled room temperature 20 – 25°C (68 – 77°F) [see USP].

Rx Only

Manufactured by:

Pfizer Ireland Pharmaceuticals

Dublin, Ireland

LAB-0021-23.0

February 2009

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